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1. Neurodevelopmental outcomes of infants after in utero exposure to SARS-CoV-2 or mRNA-COVID-19 vaccine compared with unexposed infants: a COVI-PREG prospective cohort study

Author

Favre, Guillaume, Bromley, Rebecca L., Bluett-Duncan, Matthew, Maisonneuve, Emeline, Pomar, Léo, Daire, Charlotte, Radan, Anda-Petronela, Raio, Luigi, Surbek, Daniel, Blume, Carolin, Kalimeris, Stylianos, Madec, Yoann, Schneider, Juliane, Bickle Graz, Myriam, Winterfeld, Ursula, Panchaud, Alice, and Baud, David

Published
2025
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2. Discovery of DNA methylation signature in the peripheral blood of individuals with history of antenatal exposure to valproic acid

Author

Haghshenas, Sadegheh, Putoux, Audrey, Reilly, Jack, Levy, Michael A., Relator, Raissa, Ghosh, Sourav, Kerkhof, Jennifer, McConkey, Haley, Edery, Patrick, Lesca, Gaetan, Besson, Alicia, Coubes, Christine, Willems, Marjolaine, Ruiz-Pallares, Nathalie, Barat-Houari, Mouna, Tizzano, Eduardo F., Valenzuela, Irene, Sabbagh, Quentin, Clayton-Smith, Jill, Jackson, Adam, O’Sullivan, James, Bromley, Rebecca, Banka, Siddharth, Genevieve, David, and Sadikovic, Bekim

Published
2024
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3. Core Data Elements for Pregnancy Pharmacovigilance Studies Using Primary Source Data Collection Methods: Recommendations from the IMI ConcePTION Project

Author

Richardson, Jonathan L., Moore, Alan, Bromley, Rebecca L., Stellfeld, Michael, Geissbühler, Yvonne, Bluett-Duncan, Matthew, Winterfeld, Ursula, Favre, Guillaume, Alexe, Amalia, Oliver, Alison M., van Rijt-Weetink, Yrea R. J., Hodson, Kenneth K., Rezaallah, Bita, van Puijenbroek, Eugene P., Lewis, David J., and Yates, Laura M.

Published
2023
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5. Preconception counselling in women with epilepsy.

Author

Pegg, Emily J., Bromley, Rebecca, Mirza, Farhat, and Campbell, Ellen

Subjects
*DIAGNOSIS of epilepsy, *FETAL growth retardation, *PATIENT education, *BREASTFEEDING, *HUMAN abnormalities, *MATERNAL health services, *FOLIC acid, *NEURAL development, *GENETIC counseling, *PREGNANT women, *MATERNAL mortality, *PRECONCEPTION care, *EPILEPSY, *CONCEPTUAL structures, *SEIZURES (Medicine), *PREGNANCY complications, *FETAL development, *CONTRACEPTION, *ANTICONVULSANTS, *DIETARY supplements, *DISEASE risk factors, RISK factors
Abstract

Pregnancy and the postpartum period are potentially high-risk periods for women with epilepsy and their babies. All women with epilepsy should have the opportunity for preconception counselling with the aim of reducing risk, optimising outcomes for the potentially developing fetus and enabling informed decision- making. This article provides an evidence- based framework for preconception counselling discussion, including the review of diagnosis and of current antiseizure medication, the risk to the fetus in relation to antiseizure medication and maternal seizures, maternal morbidity, SUDEP risk, folic acid supplements, contraception, breastfeeding and safety advice. [ABSTRACT FROM AUTHOR]

Published
2024
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7. In utero exposure to Azathioprine in autoimmune disease. Where do we stand?

Author

Belizna, Cristina, Meroni, Pier Luigi, Shoenfeld, Yehuda, Devreese, Katrien, Alijotas-Reig, Jaume, Esteve-Valverde, Enrique, Chighizola, Cecilia, Pregnolato, Francesca, Cohen, Hannah, Fassot, Celine, Mattera, Patrick Martin, Peretti, Pascale, Levy, Alexandre, Bernard, Laurence, Saiet, Mathilde, Lagarce, Laurence, Briet, Marie, Rivière, Marianne, Pellier, Isabelle, Gascoin, Géraldine, Rakotonjanahary, Jose, Borghi, Maria Orietta, Stojanovich, Ljudmila, Djokovic, Aleksandra, Stanisavljevic, Natasa, Bromley, Rebecca, Elefant-Amoura, Elisabeth, Bahi Buisson, Nadia, Pindi Sala, Taylor, Kelchtermans, Hilde, Makatsariya, Alexander, Bidsatze, Viktoria, Khizroeva, Jamilya, Latino, Jose Omar, Udry, Sebastian, Henrion, Daniel, Loufrani, Laurent, Guihot, Anne Laure, Muchardt, Christian, Hasan, Milena, Ungeheuer, Marie Noelle, Voswinkel, Jan, Damian, Laura, Pabinger, Ingrid, Gebhart, Johanna, Lopez Pedrera, Rosario, Cohen Tervaert, Jan Willem, Tincani, Angela, and Andreoli, Laura

Published
2020
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8. The use of parent‐completed questionnaires to investigate developmental outcomes in large populations of children exposed to antiseizure medications in pregnancy

Author

Bluett‐Duncan, Matthew, primary, Bullen, Philip, additional, Campbell, Ellen, additional, Clayton‐Smith, Jill, additional, Craig, John, additional, García‐Fiñana, Marta, additional, Hughes, David M., additional, Ingham, Amy, additional, Irwin, Beth, additional, Jackson, Cerian, additional, Kelly, Teresa, additional, Morrow, James, additional, Rushton, Sarah, additional, Winterbottom, Janine, additional, Wood, Amanda G., additional, Yates, Laura M., additional, and Bromley, Rebecca L., additional

Published
2024
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10. Clinical outcomes and sustained biochemical engraftment following ex-vivo autologous stem cell gene therapy for mucopolysaccharidosis type IIIA

Author

Jones, Simon, primary, Kinsella, Jane, additional, Holley, Rebecca J., additional, Potter, Jane, additional, Booth, Claire, additional, Buckland, Karen, additional, Rust, Stewart, additional, Bromley, Rebecca, additional, Church, Heather J., additional, Lee, Helena, additional, Ford, Laura, additional, Learmonth, Yuko Ishikawa, additional, Searle, Rachel, additional, Ellison, Stuart M., additional, Wynn, Robert, additional, and Bigger, Brian, additional

Published
2024
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12. Prenatal exposure to sodium valproate and levetiracetam : consequences for neurodevelopmental outcomes?

Author

Bromley, Rebecca

Subjects
618.92, Epilepsy, Pregnancy, in utero exposure
Abstract

Research has demonstrated that prenatal exposure to antiepileptic drugs is associated with an increased risk of physical malformations. The potential risk such exposure conveys to the developing brain and therefore the later cognitive functioning of the child is now the focus of both national and international research. This thesis investigated the relationship between prenatal exposure to antiepileptic drugs and child cognitive functioning. This investigation was undertaken in three phases: a systematic review of the published literature; an original research piece investigating prenatal exposure to sodium valproate and levetiracetam and finally a critical review of the research undertaken as part of this thesis and in the wider published literature. The systematic review identified 30 studies which had investigated the cognitive abilities of children with a history of prenatal exposure to antiepileptic drugs. Methodological quality of the studies was considered against the criteria of the Newcastle Ottawa Scale. Differential findings were noted across the antiepileptic drug types, with the largest number of studies documenting increased risks associated with prenatal exposure to sodium valproate. A lack of high quality research across all antiepileptic drugs, and in particular the more recently licensed antiepileptic drugs is highlighted. In the research paper presented here children aged between five and nine years of age exposed to either levetiracetam (n=37), sodium valproate (n=40) or who were born to women with epilepsy but did not require medication (n=43) were recruited from throughout the UK. Demographic and health information was collected from prospective records and supplemented with maternal interview. Formal standardised neuropsychological assessments were undertaken to inform on the child's current level of intellectual, memory, language, attentional and executive functioning. Following adjustment for variables likely to influence child cognitive ability, prenatal exposure to sodium valproate was found to be associated with poorer intellectual and language functioning in a dose dependent manner. When stratified by dose, 57.9% of children exposed to doses of sodium valproate above 800mg daily scored below the average range for their global intellectual ability. Prenatal exposure to levetiracetam was not found to be associated with poorer cognitive functioning. The critical review highlighted a number of methodological strengths of this research, despite time and resource implications. However, consideration should be given to the retrospective nature of this cohort and the potential for recruitment bias. This thesis concludes that women who require continuation of their treatment during pregnancy to control their seizures should be counselled regarding the risks and the benefits of their treatment to allow them to make informed decisions.

Published
2012

14. Neurodevelopment of babies born to mothers with epilepsy: A prospective observational cohort study.

Author

Bromley, Rebecca L., Bullen, Philip, Campbell, Ellen, Craig, John, Ingham, Amy, Irwin, Beth, Jackson, Cerain, Kelly, Teresa, Morrow, James, Rushton, Sarah, García‐Fiñana, Marta, Hughes, David M., Winterbottom, Janine, Wood, Amanda, Yates, Laura M., Clayton‐Smith, Jill, Bromley, Rebecca, Jackson, Cerian, Bullen, Phil, and Riley, Lauren

Subjects
*TODDLERS development, *MOTHERS, *COHORT analysis, *INFANT development, *EPILEPSY
Abstract

Objective: Despite widespread monotherapy use of lamotrigine or levetiracetam during pregnancy, prospectively collected, blinded child development data are still limited. The NaME (Neurodevelopment of Babies Born to Mothers With Epilepsy) Study prospectively recruited a new cohort of women with epilepsy and their offspring for longitudinal follow‐up. Methods: Pregnant women of <21 weeks gestation (n = 401) were recruited from 21 hospitals in the UK. Data collection occurred during pregnancy (recruitment, trimester 3) and at 12 and 24 months of age. The primary outcome was blinded assessment of infant cognitive, language, and motor development on the Bayley Scales of Infant and Toddler Development (3rd edition) at 24 months of age with supplementary parent reporting on the Vinelands Adaptive Behavior Scales (2nd edition). Results: There were 394 live births, with 277 children (70%) completing the Bayley assessment at 24 months. There was no evidence of an association of prenatal exposure to monotherapy lamotrigine (−.74, SE = 2.9, 95% confidence interval [CI] = −6.5 to 5.0, p =.80) or levetiracetam (−1.57, SE = 3.1, 95% CI = −4.6 to 7.7, p =.62) with poorer infant cognition, following adjustment for other maternal and child factors in comparison to nonexposed children. Similar results were observed for language and motor scores. There was no evidence of an association between increasing doses of either lamotrigine or levetiracetam. Nor was there evidence that higher dose folic acid supplementation (≥5 mg/day) or convulsive seizure exposure was associated with child development scores. Continued infant exposure to antiseizure medications through breast milk was not associated with poorer outcomes, but the number of women breastfeeding beyond 3 months was low. Significance: These data are reassuring for infant development following in utero exposure to monotherapy lamotrigine or levetiracetam, but child development is dynamic, and future follow‐up is required to rule out later emerging effects. [ABSTRACT FROM AUTHOR]

Published
2023
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16. Monotherapy treatment of epilepsy in pregnancy: congenital malformation outcomes in the child

Author

Bromley, Rebecca, additional, Adab, Naghme, additional, Bluett-Duncan, Matt, additional, Clayton-Smith, Jill, additional, Christensen, Jakob, additional, Edwards, Katherine, additional, Greenhalgh, Janette, additional, Hill, Ruaraidh A, additional, Jackson, Cerian F, additional, Khanom, Sonia, additional, McGinty, Ronan N, additional, Tudur Smith, Catrin, additional, Pulman, Jennifer, additional, and Marson, Anthony G, additional

Published
2023
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17. Neurodevelopmental outcomes in children and adults with Fetal Valproate Spectrum Disorder: A contribution from the ConcePTION project

Author

Bluett-Duncan, Matthew, primary, Astill, Denise, additional, Charbak, Rana, additional, Clayton-Smith, Jill, additional, Cole, Susan, additional, Cook, Penny A., additional, Cozens, Jo, additional, Keely, Karen, additional, Morris, Jacki, additional, Mukherjee, Raja, additional, Murphy, Emma, additional, Turnpenny, Peter, additional, Williams, Janet, additional, Wood, Amanda, additional, Yates, Laura, additional, and Bromley, Rebecca L., additional

Published
2023
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18. Expert consensus on neurodevelopmental outcomes in pregnancy pharmacovigilance studies

Author

Bromley, Rebecca, primary, Graz, Miriam Bickle, additional, Bluett-Duncan, Matthew, additional, Chambers, Christina, additional, Damkier, Per, additional, Dietrich, Kim, additional, Dolk, Helen, additional, Grant, Kimberley, additional, Mattson, Sarah, additional, Meador, Kim, additional, Nordeng, Hedvig, additional, Oberlander, Tim, additional, Ornoy, Asher, additional, Revet, Alexis, additional, Richardson, Jonathan, additional, Rovet, Joanne, additional, Schuler-Faccini, Lavinia, additional, Smearman, Erica, additional, Simms, Victoria, additional, Vorhees, Charles, additional, Wide, Katrina, additional, Wood, Amanda, additional, Yates, Laura, additional, Ystrom, Evinid, additional, Supraja, T.A., additional, and Adams, Jane, additional

Published
2023
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20. Diagnosis and management of individuals with Fetal Valproate Spectrum Disorder; a consensus statement from the European Reference Network for Congenital Malformations and Intellectual Disability

Author

Clayton-Smith, Jill, Bromley, Rebecca, Dean, John, Journel, Hubert, Odent, Sylvie, Wood, Amanda, Williams, Janet, Cuthbert, Verna, Hackett, Latha, Aslam, Neelo, Malm, Heli, James, Gregory, Westbom, Lena, Day, Ruth, Ladusans, Edmund, Jackson, Adam, Bruce, Iain, Walker, Robert, Sidhu, Sangeet, Dyer, Catrina, Ashworth, Jane, Hindley, Daniel, Diaz, Gemma Arca, Rawson, Myfanwy, and Turnpenny, Peter

Published
2019
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21. Neurodevelopment of babies born to mothers with epilepsy: A prospective observational cohort study

Author

Bromley, Rebecca, Bullen, Philip, Campbell, Ellen, Craig, John, Ingham, Amy, Irwin, Beth, Jackson, Cerain, Kelly, Teresa, Morrow, James, Rushton, Sarah, García-Fiñana, Marta, Hughes, David M., Winterbottom, Janine, Wood, Amanda, Yates, Laura M., Clayton-Smith, Jill, the NaME Study Group, Bromley, Rebecca, Bullen, Philip, Campbell, Ellen, Craig, John, Ingham, Amy, Irwin, Beth, Jackson, Cerain, Kelly, Teresa, Morrow, James, Rushton, Sarah, García-Fiñana, Marta, Hughes, David M., Winterbottom, Janine, Wood, Amanda, Yates, Laura M., Clayton-Smith, Jill, and the NaME Study Group

Abstract

Objective: Despite widespread monotherapy use of lamotrigine or levetiracetam during pregnancy, prospectively collected, blinded child development data are still limited. The NaME (Neurodevelopment of Babies Born to Mothers With Epilepsy) Study prospectively recruited a new cohort of women with epilepsy and their offspring for longitudinal follow-up. Methods: Pregnant women of <21 weeks gestation (n = 401) were recruited from 21 hospitals in the UK. Data collection occurred during pregnancy (recruitment, trimester 3) and at 12 and 24 months of age. The primary outcome was blinded assessment of infant cognitive, language, and motor development on the Bayley Scales of Infant and Toddler Development (3rd edition) at 24 months of age with supplementary parent reporting on the Vinelands Adaptive Behavior Scales (2nd edition). Results: There were 394 live births, with 277 children (70%) completing the Bayley assessment at 24 months. There was no evidence of an association of prenatal exposure to monotherapy lamotrigine (−.74, SE = 2.9, 95% confidence interval [CI] = −6.5 to 5.0, p =.80) or levetiracetam (−1.57, SE = 3.1, 95% CI = −4.6 to 7.7, p =.62) with poorer infant cognition, following adjustment for other maternal and child factors in comparison to nonexposed children. Similar results were observed for language and motor scores. There was no evidence of an association between increasing doses of either lamotrigine or levetiracetam. Nor was there evidence that higher dose folic acid supplementation (≥5 mg/day) or convulsive seizure exposure was associated with child development scores. Continued infant exposure to antiseizure medications through breast milk was not associated with poorer outcomes, but the number of women breastfeeding beyond 3 months was low. Significance: These data are reassuring for infant development following in utero exposure to monotherapy lamotrigine or levetiracetam, but child development is dynamic, and future follow-up is required to rule o

Published
2023

24. Sustained improvement of clinical CNS and somatic features of Gaucher disease type 3 after haematopoietic stem cell (HSC) gene therapy: A first-in-world report

Author

Donald, Aimee, primary, Potter, Jane, additional, Church, Heather J., additional, Amirloo, Bahareh, additional, Cooper, James, additional, Egerton, Christine, additional, Watts, Kelly E., additional, Hutton, Rebekah A., additional, Rust, Stewart, additional, Bromley, Rebecca, additional, Stivaros, Stavros M., additional, Adera, Mathews, additional, Ridha, Essra, additional, Veselinovic, Milena, additional, Jones, Simon A., additional, Wynn, Robert, additional, and Broomfield, Alexander, additional

Published
2023
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25. Breastfeeding while on treatment with antiseizure medications:a systematic review from the ILAE Women Task Force

Author

Tomson, Torbjörn, Battino, Dina, Bromley, Rebecca, Kochen, Silvia, Meador, Kimford J, Pennell, Page B, and Thomas, Sanjeev V

Subjects
Vigabatrin/therapeutic use, Levetiracetam, Everolimus/therapeutic use, Clonazepam/therapeutic use, Fenfluramine/therapeutic use, Oxcarbazepine, Carbamazepine/therapeutic use, Lamotrigine, Clonazepam, Vigabatrin, Lacosamide, Topiramate, Fenfluramine, Ethosuximide/therapeutic use, Cannabidiol, Humans, Levetiracetam/therapeutic use, Everolimus, Prospective Studies, Valproic Acid/therapeutic use, Child, Phenytoin/therapeutic use, Tiagabine, Felbamate/therapeutic use, Epilepsy, Clobazam/therapeutic use, Lamotrigine/therapeutic use, Valproic Acid, Infant, Zonisamide/therapeutic use, General Medicine, Felbamate, Carbamazepine, Breast Feeding, Neurology, Zonisamide, Phenobarbital, Phenytoin, Clobazam, Ethosuximide, Female, Neurology (clinical), Phenobarbital/therapeutic use, Gabapentin, Epilepsy/drug therapy, Gabapentin/therapeutic use
Abstract

We carried out a systematic review of published information on transfer of antiseizure medications (ASMs) into breastmilk, ASM serum concentrations in breastfed infants, and the wellbeing of infants breastfed by mothers on ASM treatment. Information was extracted from 85 relevant articles. No data on ASM levels in breastmilk or in breastfed infants was identified for cannabidiol, cenobamate, clobazam, eslicarbazepine-acetate, everolimus, felbamate, fenfluramine, retigabine, rufinamide, stiripentol, tiagabine, and vigabatrin. For ASMs, with available information on levels in breastfed infants, very low concentrations (in the order of 10% or less of maternal serum concentrations) were reported for carbamazepine, gabapentin, levetiracetam, oxcarbazepine, phenytoin, valproate, and clonazepam. Slightly higher levels (up to approximately 30% of maternal serum concentrations) have been observed with lamotrigine and topiramate, and in single case reports for brivaracetam, lacosamide, and perampanel. High infant levels (30% up to 100% of maternal serum concentrations) have been reported with ethosuximide, phenobarbital and zonisamide. Adverse infant effects during breastfeeding by mothers on ASMs appear to be rare regardless of the type of ASM, but systematic study is limited. Prospective long-term follow-up studies of developmental outcomes among children who have been breastfed by mothers taking ASMs are sparse and have mainly involved children whose mothers were taking carbamazepine, lamotrigine, levetiracetam, phenytoin or valproate as monotherapy while breastfeeding. Although these studies have not indicated poorer outcome among breastfed children compared with those who were not breastfed, further data on long-term outcomes are needed to draw firm conclusions. It is concluded that breastfeeding should in general be encouraged in women taking ASMs, given the well-established benefits of breastfeeding with regard to both short- and long-term infant health in the general population. Counselling needs to be individualized including information on the current knowledge regarding the woman's specific ASM treatment.

Published
2022
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28. Human teratogens and their impact on the developing brain: a scoping review

Author

Bluett-Duncan, Matthew and Bromley, Rebecca

Subjects
Teratology, Neuroscience and Neurobiology, Mental and Social Health, Pharmacology, Toxicology and Environmental Health, Neurodevelopment, Life Sciences, Psychiatry and Psychology, Chemicals and Drugs, Medicines, Pharmacovigilance, Child Development, Pregnancy, Medicine and Health Sciences, reproductive and urinary physiology
Abstract

The impact of certain medication exposures in utero can be observed in the physical development of the fetus (e.g. patterns of congenital malformations or dysmorphic features) or in the form of growth disruption. Developmental trajectories within the fetal brain can also be susceptible to alteration and can manifest as lifelong neurodevelopmental impairments. Despite growing recognition of its importance as an outcome, a lack of coherence within the investigation of the neurodevelopmental outcomes remains. Important methodological clarity could be gained through reviewing published data regarding neurodevelopmental outcomes within the context of confirmed structural teratogens. This scoping review will use systematic searches to identify neurodevelopmental outcome data for medications demonstrated to alter the physical development of the fetus (i.e. structural malformations or growth disruption). Searches will be conducted in MEDLINE, EMBASE, and the specialized database Reprotox. Identified abstracts will be doubly reviewed against the eligibility criteria and data extracted. A narrative review will be undertaken, reporting on the key neurodevelopmental areas frequently altered, methodological features of completed studies (e.g. study designs, child characteristics, dose relationships, etc) and, importantly, the relationship between the structural alterations associated with the exposure and the observed neurodevelopmental outcomes.

Published
2022
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29. Report with core data elements to collect long term outcomes (D2.7)

Author

Bromley, Rebecca, Matthew Bluett -Duncan, Yates, Laura, Geissbühler, Yvonne, Moore, Lan, Richardson, Jonathan Luke, and Stellfelt, Michael

Abstract

Report describing core data elements for the collection of pregnancy, immediate child outcomes and longer-term child outcomes in medication exposed pregnancies.

Published
2022
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33. The prevalence of neurodevelopmental disorders in children prenatally exposed to antiepileptic drugs

Author

Bromley, Rebecca Louise, Mawer, George E, Briggs, Maria, Cheyne, Christopher, Clayton-Smith, Jill, García-Fiñana, Marta, Kneen, Rachel, Lucas, Sam B, Shallcross, Rebekah, Baker, Gus A, Baker, Gus, Briggs, Maria, Bromley, Rebecca, Clayton-Smith, Jill, Dixon, Pete, Fryer, Alan, Gummery, Alison, Kneen, Rachel, Kerr, Loretta, Lucas, Sam, Mawer, George, and Shallcross, Rebekah

Published
2013
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37. Report describing existing coding systems, schemes and regulatory guidelines of reported medication exposed pregnancies (D2.3)

Author

Yates, Laura, Lewis, David, Bromley, Rebecca, Richardson, Johnathan, Geissb��hler, Yvonne, Moore, Alan, Stellfelt, Michael, and Oliver, Alison

Abstract

By describing a sequence of reviews, this report aims to document current practice from which routes for improvement can be identified and implemented into future endeavours of the ConcePTION project. The reviews emphasize present regulatory frameworks regarding the collection of data on exposed pregnancies, on large-scale data collection schemes, and on how data reported through industry pharmacovigilance systems are coded and communicated to regulators.

Published
2020
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38. Breastfeeding while on treatment with antiseizure medications: a systematic review from the ILAE Women Task Force

Author

Tomson, Torbjörn, Battino, Dina, Bromley, Rebecca, Kochen, Silvia, Meador, Kimford J., Pennell, Page B., and Thomas, Sanjeev V.

Abstract

We carried out a systematic review of published information on transfer of antiseizure medications (ASMs) into breastmilk, ASM serum concentrations in breastfed infants, and the wellbeing of infants breastfed by mothers on ASM treatment. Information was extracted from 85 relevant articles. No data on ASM levels in breastmilk or in breastfed infants was identified for cannabidiol, cenobamate, clobazam, eslicarbazepine‐acetate, everolimus, felbamate, fenfluramine, retigabine, rufinamide, stiripentol, tiagabine, and vigabatrin. For ASMs, with available information on levels in breastfed infants, very low concentrations (in the order of 10% or less of maternal serum concentrations) were reported for carbamazepine, gabapentin, levetiracetam, oxcarbazepine, phenytoin, valproate, and clonazepam. Slightly higher levels (up to approximately 30% of maternal serum concentrations) have been observed with lamotrigine and topiramate, and in single case reports for brivaracetam, lacosamide, and perampanel. High infant levels (30% up to 100% of maternal serum concentrations) have been reported with ethosuximide, phenobarbital and zonisamide. Adverse infant effects during breastfeeding by mothers on ASMs appear to be rare regardless of the type of ASM, but systematic study is limited. Prospective long‐term follow‐up studies of developmental outcomes among children who have been breastfed by mothers taking ASMs are sparse and have mainly involved children whose mothers were taking carbamazepine, lamotrigine, levetiracetam, phenytoin or valproate as monotherapy while breastfeeding. Although these studies have not indicated poorer outcome among breastfed children compared with those who were not breastfed, further data on long‐term outcomes are needed to draw firm conclusions. It is concluded that breastfeeding should in general be encouraged in women taking ASMs, given the well‐established benefits of breastfeeding with regard to both short‐ and long‐term infant health in the general population. Counselling needs to be individualized including information on the current knowledge regarding the woman's specific ASM treatment.

Published
2022
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43. An international registry for emergent pathogens and pregnancy

Author

Alice Panchaud, Guillaume Favre, Leo Pomar, Manon Vouga, Karoline Aebi-Popp, David Baud, Tallarek Ann-Christin, Strizek Brigitte, Hecher Kurt, Böckenhoff Paul, Schrey-Petersen Susanne, Mullins Edward, Bromley Rebecca, Whitehead Clare, Rolnik Daniel, Deprest Jan, Richter Jute, Gomes Luz Adriana, Bohrer Betania, Carvalho Ribeiro-do-Valle Carolina, Garanhani Surita Fernanda, Schuler-Faccini Lavinia, Osorio Wender Maria Celeste, Da Rocha Oppermann Maria Lucia, Moreira de sa Renato Augusto, Quintana Silvana, Sjaus Ana, Rahman Arifa, Hamel-Thibault Audrey, Nash Christopher, Kakkar Fatima, Berger Howard, Boucoiran Isabelle, Pasquier Jean-Charles, Snelgrove John, Zipursky Jonathan, Lacroix Meagan, Whittle Wendy, Fuenzalida Javiera, Carvajal Jorge, Guerra Canales Manuel, Hernandez Olivia, Yin Mingzhu, Chen Xiang, Qi Xiaolong, Sanín Blair José Enrique, Gonzalez Ricardo, Cano Aguilar Africa, Rodriguez Vicente Agueda, Tubau Navarra Albert, Puertas Prieto Alberto, Cano Garcia Alejandra Maria, Carrascal Cumplido Ana, Villalba Yarza Ana, Filloy Lavia Ana Cristina, Fernandez Alonso Ana Maria, Sanchez Vegazo Garcia Angeles, Goncé Anna, Ruano Garcia Antonio, Sanchez Munoz Antonio, Marcos Puig Beatriz, Munoz Abellana Begona, Garrido Luque Belen, Fernandez Fernandez Camino, Larranaga Azcarate Carlos, Baena Luque Carmen, Orizales Lago Carmen Maria, Alvarez Colomo Cristina, Lesmes Heredia Cristina, Ruiz Aguilar Cristina, Ferriols Perez Elena, Pascual Salvador Elena, Carmona Sanchez Encarnacion, Alvarez Silvares Esther, Canedo Carballeira Esther Maria, Moran Antolin Eva, Muelas Parraga Eva Maria, Oviedo Perez Eva Maria, Gonzalez Carvajal Francisco Jesus, Agudo Iène, Ocerin Bengoa Iratxe, Gastaca Abasolo Irene, Cabello de Alba Fernandez Isabel, Alvarez Javier, Duro Gomez Jorge, Atxotegi Jose, Navarrina Martinez José, Ruiz Aragon José, Sainz Bueno José Antonio, Adanez Garcia Jose Manuel, Broullon Molanes José Roman, Wizner de Alva Juan Carlos, Forcen Acebal Laura, Gonzalez Rodriguez Laura, Aceituno Velasco Longinos, Cerrillos Gonzalez Lucas, Trigo Lucas, Diaz Meca Lucia, Parada Millan M Carmen, Molina Oller Magdalena, Dominguez Gonzalez Manuel, Munoz Chapuli Gutierrez Mar, Caridad Ortiz Herrera Maria, Nieves Quesada Fernandez Maria, Suarez Arana Maria, Teulon Gonzalez Maria, Zafra Bailera Maria, Duenas Carazo Maria Begona, Gonzalez Macias Maria Carmen, Pilar Guadix Martin Maria del, Barbancho Lopez Maria del Carmen, Medina Mallen Maria del Carmen, Pardo Pumar Maria Isabel, Gimeno Gimeno Maria Joaquina, Nunez Valera Maria José, Pelegay Escartin Maria José, Camacho Caro Marta, Garcia Sanchez Marta, Meca Casbas Marta Ruth, Fraca Padilla Mercedes, Ramirez Gomez Mercedes, Catalina Coello Monica, Cruz Lemini Monica, Perez Perez Noelia, Nieto Velasco Olga, Alomar Mateu Onofre, Martinez Perez Oscar, Vaquerizo Ruiz Oscar, Barrio Fernández Pablo Guillermo del, Monteliu Gonzalez Pilar, Prats Rodriguez Pilar, Vivaracho Terrer Porfirio, Gonzales Seoane Raquel, Jimenez Velazquez Raquel, Alvarez Fernandez Rebeca, Lopez Perez Rocio, Ostos Serna Rosa Maria, Redondo Aguilar Rosario, Bernardo Vega Rut, Cano Sandra, Mateos Lopez Silvia, Fernandez Garcia Susana, Soldevilla Perez Susana, Manrique Gomez Tania, Munoz Carmona Vitor, Ko Albert I, Johnson Anthony, Nielsen Saines Karin, Cambou Mary, Grechukhina Olga, Neupane Sahara, Reddy Uma, Shah Zubin, Breton Bénédicte, Garabedian Charles, Bertholdt Charline, Poncelet Christophe, Subtil Damien, Musso Didier, Henry Estelle, Plantefeve Gaetan, Ducarme Guillaume, Pelerin Helene, Dimet Jerome, Cottin Judith, Stiremann Julien, Lambert Véronique, Hcini Najeh, Salomon Laurent, Sentilhes Loïc, Giral Marylene, Mottet Nicolas, Morel Olivier, Rozenberg Patrick, Lucie Sedille, Quibel Thibaud, Karagianni Vasiliki, Equy Véronique, Ville Yves, Carles Gabriel, Ruehl Ina, Cleary Brian, Malone Fergal, Higgins Mary, Geary Michael, Hadar Eran, Malinger Gustavo, Sela Hen, Krajden Haratz Karina, Maymon Ron, Yogev Yariv, De Luca Carmen, De Santis Marco, Rosso Telefono, Atallah David, Boguziene Emilija, Germes Pina Fernando, Van den Akker Thomas, Gil-Guevara Enrique, Marchena Jeannette, Ventura Walter, Pereira Alcides, Ayres de Campos Diogo, Charepe Nadia, Viana Pinto Pedro, Ntasumbumuyange Diomede, Rulisa Stephen, Panchaud Alice, Radan Anda-Petronela, Papadia Andrea, Bloch Andrea, Feki Anis, Muller Brochut Anne-Claude, Toussaint Arnaud, Eggel-Hort Béatrice, Martinez de Tejada Begoña, Frey Tirri Brigitte, Weber Brigitte, Blume Carolin, Monod Cécile, Kahlert Christian, Voekt Cora, Surbek Daniel, Baud David, Bassler Dirk, Mueller Doris, Prentl Elke Barbara, Gerber Eva, Rothe Friederike, Eric Giannoni, Favre Guillaume, Hoesli Irene, Mathis Jérôme, Lepigeon Karine, Aebi-Popp Karoline, Pomar Leo, Schäffer Leonhard, Raio Luigi, Vouga Manon, Huesler Charles Margaret, Rossier Marie-Claude, Hodel Markus, Kaufmann Martin, Gavillet Mathilde, Boulvain Michel, Todesco Bernasconi Monya, Bickle Myriam, Ochsenbein Kölble Nicole, Jarrah Omar, Kanellos Panagiotis, Brasier Lutz Pascale, Capoccia Brugger Romina, Heldstab Sandra, Heldstab Sandra Andrea, Rouiller Cornu Sylvie, Fischer Tina, Winterfeld Ursula, Lambelet Valentine, Rieder Wawrzyniec, Greub Gilbert, Gengler Carole, Patel Rena C, Huespe Miguel Angel, Nieto-Calvache Albaro José, COVI-Preg group, Ann-Christin, T., Brigitte, S., Kurt, H., Paul, B., Susanne, S.P., Edward, M., Rebecca, B., Clare, W., Daniel, R., Jan, D., Jute, R., Adriana, G.L., Betania, B., Carolina, C.R., Fernanda, G.S., Lavinia, S.F., Maria Celeste, O.W., Maria Lucia, DRO, Renato Augusto, M.S., Silvana, Q., Ana, S., Arifa, R., Audrey, H.T., Christopher, N., Fatima, K., Howard, B., Isabelle, B., Jean-Charles, P., John, S., Jonathan, Z., Meagan, L., Wendy, W., Javiera, F., Jorge, C., Manuel, G.C., Olivia, H., Mingzhu, Y., Xiang, C., Xiaolong, Q., José Enrique, S.B., Ricardo, G., Africa, C.A., Agueda, R.V., Albert, T.N., Alberto, P.P., Alejandra Maria, C.G., Ana, C.C., Ana, V.Y., Ana Cristina, F.L., Ana Maria, F.A., Angeles, SVG, Anna, G., Antonio, R.G., Antonio, S.M., Beatriz, M.P., Begona, M.A., Belen, G.L., Camino, F.F., Carlos, L.A., Carmen, B.L., Carmen Maria, O.L., Cristina, A.C., Cristina, L.H., Cristina, R.A., Elena, F.P., Elena, P.S., Encarnacion, C.S., Esther, A.S., Esther Maria, C.C., Eva, M.A., Eva Maria, M.P., Eva Maria, O.P., Francisco Jesus, G.C., Iène, A., Iratxe, O.B., Irene, G.A., Isabel, CAF, Javier, A., Jorge, D.G., Jose, A., José, N.M., José, R.A., José Antonio, S.B., Jose Manuel, A.G., José Roman, B.M., Juan Carlos, W.A., Laura, F.A., Laura, G.R., Longinos, A.V., Lucas, C.G., Lucas, T., Lucia, D.M., M Carmen, P.M., Magdalena, M.O., Manuel, D.G., Mar, MCG, Maria, COH, Maria, NQF, Maria, S.A., Maria, T.G., Maria, Z.B., Maria Begona, D.C., Maria Carmen, G.M., Maria Del, PGM, Maria Del Carmen, B.L., Maria Del Carmen, M.M., Maria Isabel, P.P., Maria Joaquina, G.G., Maria José, N.V., Maria José, P.E., Marta, C.C., Marta, G.S., Marta Ruth, M.C., Mercedes, F.P., Mercedes, R.G., Monica, C.C., Monica, C.L., Noelia, P.P., Olga, N.V., Onofre, A.M., Oscar, M.P., Oscar, V.R., Pablo Guillermo Del, B.F., Pilar, M.G., Pilar, P.R., Porfirio, V.T., Raquel, G.S., Raquel, J.V., Rebeca, A.F., Rocio, L.P., Rosa Maria, O.S., Rosario, R.A., Rut, B.V., Sandra, C., Silvia, M.L., Susana, F.G., Susana, S.P., Tania, M.G., Vitor, M.C., Albert I, K., Anthony, J., Karin, N.S., Mary, C., Olga, G., Sahara, N., Uma, R., Zubin, S., Bénédicte, B., Charles, G., Charline, B., Christophe, P., Damien, S., Didier, M., Estelle, H., Gaetan, P., Guillaume, D., Helene, P., Jerome, D., Judith, C., Julien, S., Véronique, L., Najeh, H., Laurent, S., Loïc, S., Marylene, G., Nicolas, M., Olivier, M., Patrick, R., Sedille, L., Thibaud, Q., Vasiliki, K., Véronique, E., Yves, V., Gabriel, C., Ina, R., Brian, C., Fergal, M., Mary, H., Michael, G., Eran, H., Gustavo, M., Hen, S., Karina, K.H., Ron, M., Yariv, Y., Carmen, L., Marco, S., Telefono, R., David, A., Emilija, B., Fernando, G.P., Thomas, VDA, Enrique, G.G., Jeannette, M., Walter, V., Alcides, P., Diogo, A.C., Nadia, C., Pedro, V.P., Diomede, N., Stephen, R., Alice, P., Anda-Petronela, R., Andrea, P., Andrea, B., Anis, F., Anne-Claude, M.B., Arnaud, T., Béatrice, E.H., Begoña, M.T., Brigitte, F.T., Brigitte, W., Carolin, B., Cécile, M., Christian, K., Cora, V., Daniel, S., David, B., Dirk, B., Doris, M., Elke Barbara, P., Eva, G., Friederike, R., Giannoni, E., Guillaume, F., Irene, H., Jérôme, M., Karine, L., Karoline, A.P., Leo, P., Leonhard, S., Luigi, R., Manon, V., Margaret, H.C., Marie-Claude, R., Markus, H., Martin, K., Mathilde, G., Michel, B., Monya, T.B., Myriam, B., Nicole, O.K., Omar, J., Panagiotis, K., Pascale, B.L., Romina, C.B., Sandra, H., Sandra Andrea, H., Sylvie, R.C., Tina, F., Ursula, W., Valentine, L., Wawrzyniec, R., Gilbert, G., Carole, G., Rena C, P., Miguel Angel, H., and Albaro José, N.C.

Subjects
Diagnostic Screening Programs, medicine.medical_specialty, 2019-20 coronavirus outbreak, Coronavirus disease 2019 (COVID-19), Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), Pneumonia, Viral, Severe Acute Respiratory Syndrome, Communicable Diseases, Emerging, Risk Assessment, Betacoronavirus, Fetus, Pregnancy, Risk Factors, Pandemic, medicine, Humans, Registries, 610 Medicine & health, Intensive care medicine, Pandemics, Zika Virus Infection, Viral Epidemiology, business.industry, Pregnancy Outcome, Betacoronavirus/growth & development, Betacoronavirus/immunology, Communicable Diseases, Emerging/epidemiology, Communicable Diseases, Emerging/prevention & control, Coronavirus Infections/epidemiology, Diagnostic Screening Programs/standards, Female, Interdisciplinary Placement/methods, Pneumonia, Viral/epidemiology, Pregnancy Outcome/epidemiology, Severe Acute Respiratory Syndrome/epidemiology, Zika Virus/immunology, Zika Virus Infection/epidemiology, COVID-19, Zika Virus, General Medicine, medicine.disease, Interdisciplinary Placement, sars-cov-2, Settore MED/40 - GINECOLOGIA E OSTETRICIA, Coronavirus Infections, business
Published
2020

44. Additional file 3: of Diagnosis and management of individuals with Fetal Valproate Spectrum Disorder; a consensus statement from the European Reference Network for Congenital Malformations and Intellectual Disability

Author

Clayton-Smith, Jill, Bromley, Rebecca, Dean, John, Journel, Hubert, Odent, Sylvie, Wood, Amanda, Williams, Janet, Cuthbert, Verna, Hackett, Latha, Neelo Aslam, Malm, Heli, James, Gregory, Westbom, Lena, Day, Ruth, Ladusans, Edmund, Jackson, Adam, Bruce, Iain, Walker, Robert, Sangeet Sidhu, Dyer, Catrina, Ashworth, Jane, Hindley, Daniel, Diaz, Gemma, Rawson, Myfanwy, and Turnpenny, Peter

Abstract

Summary sheet for General Practitioners. (PPTX 115 kb)

Published
2019
Full Text
View/download PDF

45. Additional file 5: of Diagnosis and management of individuals with Fetal Valproate Spectrum Disorder; a consensus statement from the European Reference Network for Congenital Malformations and Intellectual Disability

Author

Clayton-Smith, Jill, Bromley, Rebecca, Dean, John, Journel, Hubert, Odent, Sylvie, Wood, Amanda, Williams, Janet, Cuthbert, Verna, Hackett, Latha, Neelo Aslam, Malm, Heli, James, Gregory, Westbom, Lena, Day, Ruth, Ladusans, Edmund, Jackson, Adam, Bruce, Iain, Walker, Robert, Sangeet Sidhu, Dyer, Catrina, Ashworth, Jane, Hindley, Daniel, Diaz, Gemma, Rawson, Myfanwy, and Turnpenny, Peter

Abstract

Summary sheet for Psychologists. (PPTX 102 kb)

Published
2019
Full Text
View/download PDF

47. Additional file 4: of Diagnosis and management of individuals with Fetal Valproate Spectrum Disorder; a consensus statement from the European Reference Network for Congenital Malformations and Intellectual Disability

Author

Clayton-Smith, Jill, Bromley, Rebecca, Dean, John, Journel, Hubert, Odent, Sylvie, Wood, Amanda, Williams, Janet, Cuthbert, Verna, Hackett, Latha, Neelo Aslam, Malm, Heli, James, Gregory, Westbom, Lena, Day, Ruth, Ladusans, Edmund, Jackson, Adam, Bruce, Iain, Walker, Robert, Sangeet Sidhu, Dyer, Catrina, Ashworth, Jane, Hindley, Daniel, Diaz, Gemma, Rawson, Myfanwy, and Turnpenny, Peter

Abstract

Summary sheet for Educators. (PPTX 114 kb)

Published
2019
Full Text
View/download PDF

48. Additional file 1: of Diagnosis and management of individuals with Fetal Valproate Spectrum Disorder; a consensus statement from the European Reference Network for Congenital Malformations and Intellectual Disability

Author

Clayton-Smith, Jill, Bromley, Rebecca, Dean, John, Journel, Hubert, Odent, Sylvie, Wood, Amanda, Williams, Janet, Cuthbert, Verna, Hackett, Latha, Neelo Aslam, Malm, Heli, James, Gregory, Westbom, Lena, Day, Ruth, Ladusans, Edmund, Jackson, Adam, Bruce, Iain, Walker, Robert, Sangeet Sidhu, Dyer, Catrina, Ashworth, Jane, Hindley, Daniel, Diaz, Gemma, Rawson, Myfanwy, and Turnpenny, Peter

Abstract

Summary sheet for Patients and Parents. (PPTX 102 kb)

Published
2019
Full Text
View/download PDF

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